Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008537309

FEI Number

3008537309

Entity Name

Grupo American Industries, S.A. De C.V

City/State/Country

Ciudad Juarez Chihuahua, MX

Establishment Address

V. SANTIAGO TRONCOSO #281, INTERIOR 1 COLONIA PAQUIME, Ciudad Juarez Chihuahua 32599, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

FOREFRONT MEDICAL AMERICAS PTE. LTD. (Owner Number: 10090828)

Owner / Operator Contact Address

35 Joo Koon Circle, Singapore, SG-05 629110, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PowerLoc Safety Infusion Set MiniLoc Safety Infusion Set PowerLoc Max Power-Injectable Infusion Set; SafeStep Huber Needle Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2024-06-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-06-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-06-23
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-06-24

Official Correspondent

Vincent Ng

US Agent Details

Mark Gauvain Email: mark.gauvain@forefrontmedical.com Phone: (978) 8042279

Related Public Records

Same Entity

FOREFRONT MEDICAL AMERICAS PTE. LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K912423	Med Institute, Inc.	VITAL-PORT M.R.I. VASCULAR ACCESS SYSTEM 7012,7112	1991-07-30
K961652	Arrow Intl., Inc.	LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017	1996-07-19
K893460	Therex Corp.	A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM	1989-06-23
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

Similar Registrations

Registration Number	Establishment Name	Location
9681202	pfm medical cpp SA	LA CHAUX-DE-FONDS Neuchatel, CH
9617604	ICU Medical Healthcare Manufacturing S.A. de C.V.	Tijuana, B.C. C.P. Baja California, MX
1000523114	AngioDynamics, Inc.	Marlborough, MA, US
1319211	ANGIODYNAMICS, INC.	Queensbury, NY, US
3013750125	Medical Components, Inc.	Yuma, AZ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008537309. Last updated year: 2026. Please use registration number 3008537309 when referencing this establishment in official correspondence.